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FDA 510(k)

NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE

K-Number: K891460 · 1989-04-17

ApplicantSmith & Nephew United, Inc.
Decision Date1989-04-17
Product CodeEFQ
DecisionSubstantially Equivalent for Some Indications

Device Summary

NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew United, Inc.. It received FDA 510(k) clearance on 1989-04-17 under 510(k) number K891460. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE?

NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE is a medical device that received FDA 510(k) clearance on 1989-04-17. The listed applicant is Smith & Nephew United, Inc.. The 510(k) number is K891460.

When did NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE receive FDA 510(k) clearance?

NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE received FDA 510(k) clearance on 1989-04-17, under 510(k) number K891460.

Who is the listed applicant for NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE?

The FDA 510(k) record lists Smith & Nephew United, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE?

The FDA product code for NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE is EFQ.

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Other records listing Smith & Nephew United, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K963096ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSINGK961775PROFORE FOUR-LAYER BANDAGE SYSTEM KITK945330ALLEVYN ADHESIVEK943619CAVI-CARE CONFORMING FOAM DRESSINGK942748INTRASITEK935705ALLEVYN ISLAND WOUND DRESSING

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Related Devices (Code: EFQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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